It’s not often I see someone claim that the US medical regulation system is too lax.
The AstraZeneca vaccine was halted in the US for a month on the basis of a single, potential adverse event. Huge numbers of lives were on the line, and the US regulators were willing to hold up one of the frontrunner vaccine candidates for weeks on the basis of the faintest hint of unsafety.
There might be long-term adverse effects of the vaccine we don’t know about, though no-one I’ve heard speak about vaccines seems to think these are likely to be severe; most vaccines are very safe. But if the FDA gives approval we can confidently assume that, at least over the timescale of the trial, the vaccine is extremely safe. In fact, we can assume we have far too much evidence of safety, that it should have been approved on the basis of substantially less evidence than we have.
As far as efficacy is concerned, as I understand it the Pfizer and Moderna vaccines have very simple designs (which were pre-approved by the – again, extremely over-conservative – FDA) and are overseen by an independent data-monitoring organisation. So while I agree their incentives are perverse, their ability to distort the data should be relatively limited.
(Here’s a piece claiming the same is not true of the AZ/Oxford vaccine; I’m not sure how to evaluate this, but it’s worth noting that the author is explicitly contrasting their data with the much more reliable Pfizer and Moderna data.)
I also think you’re excessively sceptical of the evidence of long-term risks from COVID in young people. But in my case, avoiding a significant risk of (a) a really unpleasant and really long (multi-week) illness, and (b) accidentally killing people is sufficient for me to want to take a vaccine as soon as possible, even without a (in my estimation quite small, but nontrivial) risk of long-term sequelae.
It’s not often I see someone claim that the US medical regulation system is too lax.
The AstraZeneca vaccine was halted in the US for a month on the basis of a single, potential adverse event. Huge numbers of lives were on the line, and the US regulators were willing to hold up one of the frontrunner vaccine candidates for weeks on the basis of the faintest hint of unsafety.
There might be long-term adverse effects of the vaccine we don’t know about, though no-one I’ve heard speak about vaccines seems to think these are likely to be severe; most vaccines are very safe. But if the FDA gives approval we can confidently assume that, at least over the timescale of the trial, the vaccine is extremely safe. In fact, we can assume we have far too much evidence of safety, that it should have been approved on the basis of substantially less evidence than we have.
As far as efficacy is concerned, as I understand it the Pfizer and Moderna vaccines have very simple designs (which were pre-approved by the – again, extremely over-conservative – FDA) and are overseen by an independent data-monitoring organisation. So while I agree their incentives are perverse, their ability to distort the data should be relatively limited.
(Here’s a piece claiming the same is not true of the AZ/Oxford vaccine; I’m not sure how to evaluate this, but it’s worth noting that the author is explicitly contrasting their data with the much more reliable Pfizer and Moderna data.)
I also think you’re excessively sceptical of the evidence of long-term risks from COVID in young people. But in my case, avoiding a significant risk of (a) a really unpleasant and really long (multi-week) illness, and (b) accidentally killing people is sufficient for me to want to take a vaccine as soon as possible, even without a (in my estimation quite small, but nontrivial) risk of long-term sequelae.